Effect Of Strength Exercise on Respiratory Parameters, and Functional Capacity in Bariatric Surgery Patients

Effect Of Postoperative Inspiratory Muscle Training And Strength Exercise Training On Functional Capacity, Quality of Life, Respiratory Functions, Respiratory Muscle Strength And Endurance in Bariatric Surgery Patients

The aim of the investigator's study is to investigate whether postoperative inspiratory muscle training and resistance exercise training has an effect on functional capacity, respiratory functions, respiratory muscle strength and endurance in patients undergoing bariatric surgery.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid
• Intervention / Treatment: Other: Resistance Exercise Training; Other: Inspiratory Muscle Training

Detailed Description

Obesity is an important health problem that can affect the entire organ and system of the body, leading to various disorders and even death. The fact that BMI is over 40 kg / m2 is defined as morbid obesity. The most effective treatment step in morbid obesity is bariatric surgery.

The impairment of inspiratory muscle function related to obesity is associated with increased lung elastic load, excessive lengthening in the abdominal muscles, and dissolution of the diaphragm, leading to inspiratory muscle weakness and insufficiency. The decrease in its endurance is explained by the decrease of glycogen synthase activity in skeletal muscles. It was found that there was less decrease in the inspiratory muscle training patients whose MIP values were measured before bariatric surgery compared to those who could not do MIP values after surgery.

Respiratory functions due to obesity are impaired due to restrictive mass increase in chest wall, tendency to breathe in low lung volumes and the effect of fat distribution on pleural pressure. Total lung volume, expiratory reserve volume (ERV), reserve volume (RV), vital capacity (VC), functional residual capacity (FRC), FVC, and FEV1 values are low.

After bariatric surgery, patients' muscle strength decreased. In particular, there was a decrease in muscle strength in quadriceps, hamstring, biceps, triceps. The decrease in muscle strength after surgery has been associated with a decrease in muscle mass. It was stated that patients who did not exercise after surgery lost 7.6 kg of muscle, which was 29.7% of the total lost body weight. Resistance exercises performed after bariatric surgery have a positive impact on patients' muscle strength and functional capacity.

Obesity causes a decrease in functional capacity. Increased step width, reduced walking speed and step length are shown for the main reasons. Decreased inspiratory muscle strength in patients undergoing surgery causes weakness in peripheral muscles. This weakness in peripheral muscles also reduces the functional capacity of patients. Inspiratory muscle training studies increase the functional capacity.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bezmiâlem Vakıf Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Having a body mass index (BMI) ≥40kg / m2 or
• (BMI) ≥35kg/m2 and at least one concomitant disease associated with obesity
• To participate regularly in treatment

Exclusion Criteria:

• Using assistive device while walking
• Lung infection in the past 1 month
• Chronic obstructive pulmonary disease (COPD)
• Having an orthopedic, neurological disease that will prevent him/her from exercising
• Uncontrollable hypertension
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistance Exercise Training Group; Resistance exercise training for 8 major muscle groups and 150 min per week walking suggestions were given	Other: Resistance Exercise Training; 60 minutes resistance exercise training for 8 major muscle groups (quadriceps, hamstring, biceps, triceps, pectoralis major, gluteus medius , gluteus maximus, middle part of deltoid) for 8 weeks, 3 times per week
Experimental: Inspiratory Muscle Training Group; Resistance exercise training for 8 major muscle groups and inspiratory muscle strength training and 150 min per week walking suggestions were given	Other: Resistance Exercise Training; 60 minutes resistance exercise training for 8 major muscle groups (quadriceps, hamstring, biceps, triceps, pectoralis major, gluteus medius , gluteus maximus, middle part of deltoid) for 8 weeks, 3 times per week; Other: Inspiratory Muscle Training; with % 30 of MIP, 20 minutes inspiratory muscle training for 8 weeks, 3 times per week
No Intervention: Control Group; 150 min per week walking suggestions were given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Vital Capacity (FVC)	Respiratory Function Test	3 months
Forced Expiratory Volume in 1 second (FEV1)	Respiratory Function Test	3 months
FEV1/FVC	Respiratory Function Test	3 months
Peak Expiratory Flow (PEF)	Respiratory Function Test	3 months
Forced expiratory flow over the middle one half of the FVC (FEF25-75%)	Respiratory Function Test	3 months
maximum inspiratory pressure (MIP)	Respiratory Muscle Strength Test	3 months
Maximal Voluntary Ventilation	Respiratory Muscle Endurance Test	3 months
Hand-held Dynamometer	Dynamic Muscle Strength Test	3 months
5 times sit to stand test	Mobility Test	3 months
6 minutes walking test	functional capacity test	3 months
Quality of Life Scale Specific for Obese Persons	Quality of Life	3 months
maximum expiratory pressure (MEP)	Respiratory Muscle Strength Test	3 months
Hand grip dynamometer	Static Peripheral Muscle Strength Test	3 months

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Study Chair: Alis Kostanoğlu, Assistant professor

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2019
• Primary Completion (Actual): May 21, 2020
• Study Completion (Actual): June 18, 2020

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; bariatric surgery; functional capacity; respiratory muscle endurance; resistance exercise training; 6 - Minute Walk Test; inspiratory muscle strength; peripheral muscle strength
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: BVUtacar01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No